Collection: Fast Track Requests
FDA documents available for fast-track requests typically delivered within 1 to 2 weeks. Our fast-track request service identifies previously requested and redacted documents for quick access.
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FDA Form 483 – NYU Langone Health Hospital (FEI 2470026), Sep 2024
Regular price $69.00 USDRegular priceUnit price / per -
FDA Complaints Regarding Compounded Semaglutide and Tirzepatide (Since Jan 2023)
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FDA Investigations – Aveanna Food Packaging, Labeling, and Outbreaks (Since Jan 2023)
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FDA DMF Submission Packets – Serratiopeptidase, Specialty Enzymes and Biochemicals Co.
Regular price $69.00 USDRegular priceUnit price / per -
FDA Form 483 – Marcus Research Laboratory, Inc. (FEI 1950348), Jul 2024
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FDA Correspondence Regarding GRAS Notice GRN 001144 – Miracle Fruit Powder
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FDA FAERS Reports – Imcivree (Setmelanotide) Case IDs
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FDA Inspection Records Since May 1, 2024 – Detailed Data Request
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FDA Inspection Reports – Taylor Farms Colorado Inc. (FEI 1783599)
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FDA Documentation – FCN 74 by LANXESS Corporation
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FDA Documents Relating to FCN 1531
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FDA ANDA 078553 Submission Documents – Diclofenac Sodium Ophthalmic Solution, 0.1%
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FDA Communications on Seafood List Market Name Changes for Multiple Fish Species
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FDA Comment Filed by Buchanan Ingersoll & Rooney – Docket No. FDA-2024-P-1715
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FDA Testing Records for September 20, 2024 Pet Food Advisory – Darwin’s Natural Selections
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FDA FAERS Adverse Event Reports – Leqembi/Lecanemab Case IDs
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FDA EIR and Closing Letter – American Laboratories, LLC (FEI 3002773682), Inspection ID 1209575
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FDA Inspection Communications and Reports – Patheon Manufacturing Services LLC (FEI 1018495)
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FDA Internal Memoranda for Color Additive Petitions – Spirulina Extract
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FDA Inspection Reports and Documentation for Center for Reproductive Health Fertility Lab (FEI 3005057005)
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FDA EIR for Charles River Laboratories (FEI 1813181) – Biologics Inspection, Jan 2024
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FDA List of 503a Compounding Pharmacies in the US
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FDA Regulatory Actions and Inspections of Pharmathen Facilities (July–October 2024)
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FDA Regulatory Actions – Cipla Goa/Indore (July–Oct 2024)
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FDA Citizen Petition Comment – Buchanan Ingersoll Rooney (FDA-2024-P-1715)
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FDA Pet Food Testing Records – Darwin’s Natural Selections (Sept 2024)
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FDA 510(k) Contents – Ovulon Monitor (K973860)
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FDA Inspection Reports – Terumo Puerto Rico & Terumo Medical
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FDA Label Request – K-TAB RLD for ANDA Filing
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FDA Review Files – NDA 214755 Lumryz Starter Pack Approval
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FDA FCN No. 443 – Submission, Review & Decision Documentation
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FDA EIR & 483 – Klocke of America Inc. (PDMA Inspection – Mar 2022)
Regular price $69.00 USDRegular priceUnit price / per -
FDA EIR – Jacksonville FL-Dunn (FEI 3007895922), Nov 2018
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FDA VAERS Report – Attached Document
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FDA Reports on Hand Sanitizer Shipments – EVA Entries & 483 Observations
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FDA Summary Basis of Review – ANDA A090132
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